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Medical Device File Template – In Vitro Diagnostics (EU 2017 746)

This medical device file template is set out to meet the requirements set out in Annex II and Annex III of the In Vitro Diagnostic Device Regulation EU 2017 746 for documentation required to demonstrate conformity to the regulations.

  1. Device Description
  3. Labelling
  5. Design and Manufacturing
  7. GSPRs
  9. Risk Management
  11. Verification & Validation
  13. Post Market Surveillance

    14. If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at [email protected].

      IVD Regulatory Support:

      If you are looking for support with your IVD compliance then Patient Guards consultancy services could be a cost effective solution for your organisation.

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